ADVANCE® KIMP310RRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI M684KIMP310R1), received between Mar 4, 2020 and Mar 5, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Unstable” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2024Unstable; Unstable

  ALLEGEDLY, A ZIMMER BIOMET SALES REP REPORTS A REVISION SURGERY TO PERFORM A POLY SWAP, WHICH OCCURRED ON 12/2/2024. ADDITIONAL INFORMATION RECEIVED ON 02-20-2024: POLY SWAP. INCREASED SIZE FOR STABILITY.

  Patient problems: Insufficient Information

  MAUDE report 18841851 ↗
• InjuryMar 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, OTHER. SIDE: R. REVISION NJR: 854772. GENDER: F. EXPLANTED: ALL.

  Patient problems: Insufficient Information

  MAUDE report 18841592 ↗
• InjuryJan 4, 2022Difficult to Insert; Difficult to Insert

  ALLEGEDLY, DURING THE OPERATION, THE WASHER COULD NOT BE PENETRATED. IT WAS REPEATED IT BACK FOUR MORE TIMES. AFTER MORE THAN 40 MINUTES, THE PENETRATION WAS STILL UNSUCCESSFUL. THE PATIENT'S BLEEDING INCREASED. LATER, A THICKER WASHER WAS REOPENED AND THE STROKE WAS SMOOTH ENTER. IN SURGERY THE INSERT CANNOT BE IMPLANTED SUCCESSFULLY. ALTHOUGH TRIED FOR ABOUT 40 MINUTES, IT CANNOT BE IMPLANTED. THE BLEEDING PHENOMENON GOT WORSE. SURGEON HAD TO CHANGE A THICKER ONE AND SUCCEEDED VERY EASILY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13152796 ↗
• InjuryDec 20, 2021Unstable; Unstable

  ALLEGEDLY, PATIENT WAS LOOSE, REVISED AND PUT IN A THICKER INSERT. PATELLA HAD NOT BEEN RESURFACED DURING ORIGINAL PROCEDURE SO THAT WAS DONE TOO.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13043702 ↗
• InjuryFeb 24, 2021Unstable; Unstable

  ALLEGEDLY, THIS PATIENT HAS BILATERAL KNEE REPLACEMENTS AND WAS EXPERIENCING INSTABILITY PATELLOFEMORAL PAIN. THE PATIENT UNDERWENT AN OPERATION ON BOTH KNEES. A NON-MICROPORT PATELLA WAS IMPLANTED, AND OSTEOPHYTES WERE REMOVED OFF THE OTHER PATELLA. BOTH POLYETHYLENE INSERTS WERE REPLACED.

  Patient problems: Pain

  MAUDE report 11371941 ↗
• InjuryDec 4, 2020Unstable; Naturally Worn; Unstable; Naturally Worn

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING TIBIA; INSTABILITY; WEAR OF POLYETHYLENE COMPONENT; PROGRESSIVE ARTHRITIS. REVISION NJR NUMBER: (B)(4), SIDE: R, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. MHRA REFERENCE NO: (B)(4).

  Patient problems: Arthritis

  MAUDE report 10945011 ↗
• InjuryOct 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, POSSIBLE PATELLA FEMORAL PAIN. PATELLA WAS RESURFACED AND POLY SWAPPED FOR SAME SIZE. RIGHT SIDE. COMPONENTS NOT REVISED: PRODUCT ID: 7552-0035 LOT NO: 075239808, PRODUCT ID: 7552-0030 LOT NO: 075239807, PRODUCT ID: 7552-0025 LOT NO: 085255928, PRODUCT ID: 7552-0020 LOT NO: 095273123, PRODUCT ID: SPKT-0023 LOT NO: 055175392, PRODUCT ID: KTSP-PC31 LOT NO: 035189767, PRODUCT ID: KFTC-PC3R LOT NO: 075260531.

  Patient problems: Pain

  MAUDE report 10671089 ↗
• InjuryJun 26, 2020Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. REVISION NJR NUMBER: (B)(4), SIDE: R, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: No Information

  MAUDE report 10203524 ↗
• InjuryMar 4, 2020Unstable; Unstable

  ALLEGEDLY, PATIENT IS HAVING INSTABILITY PROBLEMS IN HIS RIGHT KNEE.

  Patient problems: No Information

  MAUDE report 9787858 ↗